The following data is part of a premarket notification filed by Intuitive Surgical, Inc with the FDA for Da Vinci Xi Surgical System.
Device ID | K170713 |
510k Number | K170713 |
Device Name: | Da Vinci Xi Surgical System |
Classification | System, Surgical, Computer Controlled Instrument |
Applicant | Intuitive Surgical, Inc 1266 Kifer Road Sunnyvale, CA 94086 |
Contact | Brandon Hansen |
Correspondent | Cindy Domecus Domecus Consulting Services LLC 1171 Barroilhet Drive Hillsborough, CA 94010 |
Product Code | NAY |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-03-09 |
Decision Date | 2017-06-13 |
Summary: | summary |